Label: ASPIRIN tablet

  • NDC Code(s): 57896-901-01, 57896-901-10, 57896-901-27
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 13, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves:

    • pain and fever of colds
    • headache
    • muscle pain
    • minor pain of arthritis
    • toothache
    • menstrual pain
  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

    • facial swelling
    • shock
    • hives
    • asthma (wheezing)

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • you have asthma
    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • have bloody or black stools
      • feel faint
      • have stomach pain that does not get better
      • vomit blood
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor
  • Other information

    • use by expiration date on package
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • Inactive ingredient

    corn starch

  • Questions or comments?

    1-800-540-3765

  • Principal Display Panel

    NDC 57896-901-10

    GERICARE

    ASPIRIN
    (NSAID) • 325 mg each

    PAIN RELIEVER / FEVER REDUCER

    COMPARE TO THE ACTIVE
    INGREDIENT OF BAYER® ASPIRIN**

    1000 TABLETS

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844           REV0318B24916

    **This product is not manufactured or distributed by
    Bayer HealthCare LLC, owner of the registered
    trademark Bayer® Aspirin.

    DISTRIBUTED BY:
    GERI-CARE PHARMACEUTICAL CORP.

    1650 63 Street, Brooklyn, NY 11204

    GeriCare 44-249

    GeriCare 44-249


  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-901
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;249;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-901-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/04/1993
    2NDC:57896-901-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/04/1993
    3NDC:57896-901-27250 in 1 BOTTLE; Type 0: Not a Combination Product08/04/199308/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/04/1993
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(57896-901)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(57896-901)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(57896-901)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(57896-901)